Evidensprofiler - NKR om hysterektomi (fjernelse af livmoderen) ved godartet sygdom

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1 Evidensprofiler - NKR om hysterektomi (fjernelse af livmoderen) ved godartet sygdom Figur 1. Evidensprofil Fokuseret spørgsmål 1 (PICO 1). Subtotal eller total hysterektomi ved benign sygdom. Population: Kvinder med indikation for hysterektomi pga. benign sygdom Intervention: Subtotal hysterektomi Sammenligning: Total hysterektomi assessment patients Effect Study design Subtotal Total Reoperation pga. postoperativ intraabdominal blødning. Abdominal hysterektomi. (Repeat surgery, postoperative intraabdominal bleeding) serious 1 not serious not serious serious 2 none 1/94 (1.1%) 0/84 (0.0%) RR 2.68 (0.11 to 65.01) 0 fewer per 1000 (from 0 fewer to 0 fewer) Stressinkontinens indenfor 2 år postoperativt. - Abdominal + laparoskopisk hysterektomi (Stress urinary incontinence within 2 years post surgery) 5 randomised serious 1 not serious not serious serious 3 none 35/478 (7.3%) 25/477 (5.2%) RR 1.41 (0.86 to 2.31) 21 more per 1000 (from 7 fewer to 69 more) Tilfredshed med sex indenfor 2 år postoperativt. Abdominal hysterektomi. (Satisfaction with sex within 2 years post surgery) serious 1 serious 4 not serious serious 3 none 168/228 (73.7%) 164/226 (72.6%) RR 1.01 (0.91 to 1.13) 7 more per 1000 (from 65 fewer to 94 more) VERY Smerter ved sex indenfor 2 år postoperativt. - Abdominal hysterektomi (Prevalence of pain during sex within 2 years post surgery) serious 1 serious 4 not serious serious 3 none 19/228 (8.3%) 21/224 (9.4%) RR 0.88 (0.49 to 1.59) 11 fewer per 1000 (from 48 fewer to 55 more) VERY Prolaps (POP) indenfor 2 år postoperativt. - Abdominal + laparoskopisk hysterektomi (Pelvic prolapse within 2 years post surgery) 4 randomised serious 1 not serious not serious serious 3 none 8/414 (1.9%) 2/425 (0.5%) RR 2.70 (0.81 to 8.98) 8 more per 1000 (from 1 fewer to 38 more) Prolaps (POP grad 2) 7-11 år postoperativt. Abdominal hysterektomi. (Pelvic prolapse stage 2, 7-11 years post surgery) serious 1 not serious not serious serious 3 none 31/135 (23.0%) 28/120 (23.3%) RR 0.94 (0.62 to 1.43) 14 fewer per 1000 (from 89 fewer to 100 more) Cervikal dysplasi indenfor 12 mdr. postoperativt. Abdominal hysterektomi. (Cervical dysplasia within 12 months post surgery) serious 1 not serious not serious serious 2 none 2/90 (2.2%) 0/85 (0.0%) RR 4.73 (0.23 to 97.02) 0 fewer per 1000 (from 0 fewer to 0 fewer) 1

2 assessment patients Effect Study design Subtotal Total Livskvalitet (QoL). - Abdominal + laparoskopisk hysterektomi 3 randomised serious 1 not serious not serious serious 3 none Beskrevet narrativt under gennemgang af evidens Cyklisk vaginalblødning indenfor 2 år postoperativt. - Abdominal + laparoskopisk hysterektomi (Cyclical bleeding within 2 years post surgery) 5 randomised serious 1 not serious not serious serious 2 none 62/475 (13.1%) 3/489 (0.6%) RR (5.51 to 36.98) 81 more per 1000 (from 28 more to 221 more) Operationstid (min.) Abdominal hysterektomi. (Operating time (mins)) 4 randomised serious 1 not serious not serious not serious none MD lower (15.07 lower to 7.45 lower) MODERATE Operationstid (min.) - Laparoskopisk hysterektomi. (Operating time (mins)) serious 1 not serious not serious serious 3 none MD 5 lower (14.8 lower to 4.8 higher) Peroperativ blødning (ml) Abdominal hysterektomi. (Blood loss during surgery (mls)) 3 randomised serious 1 not serious not serious not serious none MD lower (99.58 lower to lower) MODERATE Peroperativ blødning (ml) - Laparoskopisk hysterektomi. (Blood loss during surgery (mls)) serious 1 not serious not serious serious 2 3 none MD 36 lower ( lower to higher) Sårinfektioner Postoperativt under indlæggelsen. - Abdominal + laparoskopisk hysterektomi (Wound infections, predischarge) 3 randomised serious 1 not serious not serious serious 3 none 11/363 (3.0%) 13/370 (3.5%) RR 0.86 (0.39 to 1.89) 5 fewer per 1000 (from 21 fewer to 31 more) 1. Manglende blinding kan have ført til. 2. Bredt konfidensinterval. 3. Den kliniske fremgangsmåde ville afvige, hvis den øvre versus den nedre grænse af konfidensintervallet repræsenterede sandheden. 4. Der er betydelige heterogenitet (I 2 > 50%), hvilket kan afspejle de forskellige måder at måle/vurdere resultatet. 2

3 Figur 2. Evidensprofil Fokuseret spørgsmål 2 (PICO 2). Vaginal eller konventionel laparoskopisk hysterektomi ved benign sygdom. Population: Kvinder med indikation for hysterektomi pga. benign sygdom Intervention: Konventionel laparoskopisk hysterektomi (TLH, LH, LAVH) Sammenligning: Vaginal hysterektomi assessment patients Effect Study design Laparoscopic (TLH, LH, LAVH) Vaginal Reoperation (Repeat surgery) serious 1 not serious not serious serious 2 none 0/40 (0.0%) 0/40 (0.0%) not estimable not estimable Vaginaltopsruptur (Vaginal cuff dehiscence) not reported - Læsion af naboorganer, blære eller ureter (Intraoperative visceral injury, bladder or ureter) 7 randomised serious 1 not serious not serious serious 2 none 19/687 (2.8%) 7/518 (1.4%) RR 2.03 (0.95 to 4.36) 14 more per 1000 (from 1 fewer to 45 more) Læsion af naboorganer, tarm (Intraoperative visceral injury, bowel) serious 1 not serious not serious serious 2 none 1/536 (0.2%) 0/368 (0.0%) RR 3 (0.12 to 73.2) 0 fewer per 1000 (from 0 fewer to 0 fewer) Læsioner på naboorganer der førte til konvertering til laparotomi (Intraoperative visceral injury - Unintended laparotomy) 8 randomised serious 1 not serious not serious serious 2 none 31/728 (4.3%) 17/562 (3.0%) RR 1.42 (0.83 to 2.45) 13 more per 1000 (from 5 fewer to 44 more) Inkontinens (urge- og stressinkontinens). 12 mdr. follow up. (Incontinence, urgency and stress incontinence, 12 months follow up) serious 1 not serious not serious serious 2 none 3/23 (13.0%) 3/24 (12.5%) RR 1.04 (0.23 to 4.65) 5 more per 1000 (from 96 fewer to 456 more) Livskvalitet (QoL) serious 1 not serious not serious serious 3 none Beskrevet narrativt under gennemgang af evidens 3

4 assessment patients Effect Study design Laparoscopic (TLH, LH, LAVH) Vaginal Prolaps (POP grad 1-2) 12 mdr. follow up. (Pelvic prolapse, stage 1-2) serious 1 not serious not serious very serious 2 3 none 6/23 (26.1%) 9/24 (37.5%) RR 0.7 (0.29 to 1.64) 113 fewer per 1000 (from 240 more to 266 fewer) VERY Indlæggelsestid (dage) (Length of hospital stay (days)) 9 randomised serious 1 serious 4 not serious not serious none MD 0.42 higher (0.02 lower to 0.87 higher) Operationstid (min.) (Operating time (mins)) 13 randomised serious 1 serious 4 not serious not serious none MD higher (27.69 higher to higher) Peroperativ blødning (ml) (Blood loss during surgery (mls)) 9 randomised Infektion (Infection) serious 1 serious 4 not serious not serious none MD higher (12.88 lower to higher) 14 randomised serious 1 not serious not serious serious 2 none 113/1560 (7.2%) 82/1173 (7.0%) RR 0.95 (0.73 to 1.24) 3 fewer per 1000 (from 17 more to 19 fewer) 1. Manglende blinding kan have ført til. 2. Bredt konfidensinterval. 3. Data baseret på 1 RCT. 4. Der er betydelige heterogenitet (I 2 > 50%), hvilket kan afspejle de forskellige måder at måle/vurdere resultatet. 4

5 Figur 3. Evidensprofil Fokuseret spørgsmål 3 (PICO 4). Robotassisteret laparoskopisk hysterektomi ved benign sygdom. Population: Kvinder med indikation for hysterektomi pga. benign sygdom Intervention: Robotassisteret laparoskopisk hysterektomi Sammenligning: Konventionel laparoskopisk hysterektomi assessment patients Effect Study design Robot-assisted laparoscopic Conventional laparoscopic Mortalitet (Mortality) not reported - Reoperation pga. blødning, infektion, vaginaltopsruptur og hæmatom). (Reoperation because of bleeding, infection, VCD and hematoma) serious 1 not serious not serious serious 2 3 none 4/50 (8.0%) 2/50 (4.0%) RR 2 (0.38 to 10.43) 40 more per 1000 (from 25 fewer to 377 more) Læsion af naboorganer (ureter-, tarm-, og karlæsioner). (Lesion of organs (ureter, bowel and vascular)) serious 1 not serious not serious serious 2 3 none 1/76 (1.3%) 2/76 (2.6%) RR 0.5 (0.05 to 5.34) 13 fewer per 1000 (from 25 fewer to 114 more) Vaginaltopsruptur (Vaginal cuff dehiscence) serious 1 not serious not serious serious 2 3 none 0/50 (0.0%) 1/50 (2.0%) RR 0.33 (0.01 to 7.99) 13 fewer per 1000 (from 20 fewer to 140 more) Livskvalitet (QoL) Spørgeskema: SF-36 (fysiske komponent). 6 mdr. follow up. (QoL assessed with: SF-36 (physical component) follow up: 6 months) serious 1 not serious not serious serious 2 3 none mean 1 lower (6.09 lower to 4.09 higher) Indlæggelsestid (dage) (Length of hospital stay (days)) serious 1 not serious not serious serious 3 none MD 0.2 higher (0.17 lower to 0.57 higher) Operationstid (min.) (Operating time (mins)) 5

6 assessment patients Effect Study design Robot-assisted laparoscopic Conventional laparoscopic serious 1 not serious not serious serious 4 none MD higher (14.01 higher to higher) Peroperativ blødning (ml) (Blood loss during surgery (mls)) Infektion (Infection) serious 1 not serious not serious serious 2 3 none MD 8 higher (13.02 lower to higher) serious 1 not serious not serious serious 2 3 none 2/50 (4.0%) 1/50 (2.0%) RR 2 (0.19 to 21.36) 20 more per 1000 (from 16 fewer to 407 more) 1. Manglende blinding kan have ført til. 2. Bredt konfidensinterval. 3. Den kliniske fremgangsmåde ville afvige, hvis den øvre versus den nedre grænse af konfidensintervallet repræsenterede sandheden. 4. Der er betydelige heterogenitet (I^2 > 50%), som kan afspejle de forskellige måder at måle/vurdere resultatet. 6

7 Figur 4. Evidensprofil Fokuseret spørgsmål 5 (PICO 6). Fjernelse af æggelederne i forbindelse med hysterektomi. Population: Kvinder med indikation for hysterektomi pga. benign sygdom Intervention: Hysterektomi med salpingektomi Sammenligning: Hysterektomi uden salpingektomi assessment patients Effect Study design with salpingectomy without salpingectomy Reoperation (Repeat surgery) serious 1 not serious not serious serious 2 none 3/72 (4.2%) 28/223 (12.6%) RR 0.33 (0.1 to 1.06) 84 fewer per 1000 (from 8 more to 113 fewer) VERY Operation på salpinges (pga. hydrosalpinges og pyosalpinges) follow up 0-5 år. (surgery on salpinx (hydrosalpinx and pyosalpinx) follow up 0-5 years serious 1 not serious not serious serious 2 none 0/72 (0.0%) 10/223 (4.5%) RR 0.15 (0.01 to 2.46) 38 fewer per 1000 (from 44 fewer to 65 more) VERY Tubacancer. Gns. follow up: non-pbs ** 92 mdr., PBS 55 mdr. (Tubal cancer, follow up non-pbs ** 92 months., PBS 55 months) serious 1 not serious not serious serious 2 none 0/72 (0.0%) 0/223 (0.0%) not estimable not estimable VERY Ovariecancer. Gns. follow up: non-pbs ** 92 mdr., PBS 55 mdr. (Ovarian cancer, follow up non-pbs ** 92 months., PBS 55 months) serious 1 not serious not serious serious 2 none 0/72 (0.0%) 0/223 (0.0%) not estimable not estimable VERY Anti Müllersk Hormon (AMH) ng/ml. 3 mdr. follow up. (Anti-Müllerian Hormone, follow up: 3 months) serious 3 not serious not serious serious 4 none MD 0.04 higher (1.95 lower to 2.03 higher) Anti Müllersk Hormon (AMH) ng/ml. 3 mdr. follow up. (Anti-Müllerian Hormone, follow up: 3 months) Infektion (Infection) serious 1 not serious not serious serious 2 none MD 0.02 lower (0.16 lower to 0.12 higher) VERY serious 1 not serious not serious not serious none 3/137 (2.2%) 14/145 (9.7%) RR 0.23 (0.07 to 0.77) 74 fewer per 1000 (from 22 fewer to 90 fewer) VERY 1. Historisk comparator som der ikke er justeret for. 2. Bredt konfidensinterval. 3. Manglende blinding kan have ført til. 4. Den kliniske fremgangsmåde afviger, hvis den øverste versus den nedre grænse af CI repræsenterede sandheden. 7

8 Figur 5. Evidensprofil Fokuseret spørgsmål 6 (PICO 9). Suspension af vaginaltoppen i forbindelse med hysterektomi. Population: Kvinder med indikation for hysterektomi pga. benign sygdom (ikke prolaps) Intervention: Suspension af vaginaltoppen Sammenligning: Ingen suspension af vaginaltoppen assessment patients Effect Study design suspension of the vaginal vault no suspension Prolaps (POP) (Pelvic prolapse) not reported - Stressinkontinens 6 mdr. follow up. (Stress incontinence, follow up: 6 months) very serious 1 2 not serious not serious serious 3 none 6/32 6/36 RR 1.13 (0.40 to 3.14) 22 more per 1000 (from 100 fewer to 357 more) VERY Læsion af naboorganer (skader på kar, ureter og blære) (Lesion of organs (vascular, ureter and bladder injury)) very serious 1 2 not serious not serious serious 4 none 4/32 (12.5%) 4/36 (11.1%) RR 1.13 (0.31 to 4.13) 14 more per 1000 (from 76 fewer to 348 more) VERY Reoperation (Repeat surgery) not reported - Livskvalitet (QoL) not reported - Operationstid (min.) (Operating time (mins)) very serious 1 2 not serious not serious serious 4 none mean 4.5 higher (14.88 lower to higher) VERY 1. Manglende blinding kan have ført til. 2. Randomisering med forskelle i baseline karakteristika i de to studiearme. 3. Der er lav tillid til estimaterne pga. de forskellige baseline karakteristika for stressinkontinens. 4. Bredt konfidensinterval. 8

9 Figur 6. Evidensprofil Fokuseret spørgsmål 9 (PICO 7). Sutur med eller uden modhager til lukning af vaginaltoppen ved total laparoskopisk hysterektomi. Population: Kvinder der får foretaget total laparoskopisk hysterektomi pga. benign sygdom Intervention: Sutur med modhager Sammenligning: Sutur uden modhager assessment patients Effect Study design barbed suture non-barbed suture Reoperation for vaginaltopsruptur (Repeat surgery because of vaginal cuff dehiscence) serious 1 2 not serious not serious serious 3 none 1/32 (3.1%) 1/31 (3.2%) RR 0.97 (0.06 to 14.82) 1 fewer per 1000 (from 30 fewer to 446 more) Vaginaltopsruptur (min. follow up > 1 mdr.) (Vaginal cuff dehiscence (min. follow up > 1 month)) serious 4 not serious not serious serious 5 none 1/69 (1.4%) 4/163 (2.5%) RR 0.59 (0.07 to 5.19) 10 fewer per 1000 (from 23 fewer to 103 more) VERY Infektion i vaginaltoppen, follow up: 3 uger (Infection of the vaginal cuff, follow up: 3 weeks) (follow up: 3 weeks) serious 1 2 not serious not serious serious 3 none 1/32 (3.1%) 3/31 (9.7%) RR 0.32 (0.04 to 2.94) 66 fewer per 1000 (from 93 fewer to 188 more) Postoperative infektionskomplikationer (infektioner med kendt fokus) (Postoperative infectious complications (known focus)) 2 observational serious 4 not serious not serious serious 3 5 none 5/132 (3.8%) 4/302 (1.3%) RR 2.85 (0.78 to 10.45) 25 more per 1000 (from 3 fewer to 125 more) VERY Seksuel funktion dyspareuni follow up: 3 mdr. (Sexual function - dyspareunia follow up: 3 months) (follow up: 3 months) serious 1 2 not serious not serious very serious 3 6 none 2/10 (20.0%) 1/12 (8.3%) RR 2.40 (0.25 to 22.75) 117 more per 1000 (from 63 fewer to 1000 more) VERY Kvindelig seksuel funktionsscore (FSFI, højere bedre, score-interval: 2 til 36). Follow up: 3 mdr. (Female sexual function score (FSFI, higher better, score ranges: 2 to 36). Follow up 3 months (follow up: 3 months; assessed with: Questionaire) serious 1 2 not serious not serious serious 6 none -/21 -/21 The median female sexual function score in the intervention group was 26.4 ( ) and in the comparison group the median female sexual function score was 30.1 ( ). Operationstid (min.) (Operating time (mins)) (assessed with: min.) serious 1 2 not serious serious 7 serious 3 none mean 12.5 higher (21.7 lower to 46.7 higher) VERY 1. Manglende blinding kan have ført til. 2. Loss to follow up beskrives ikke grundigt nok. 3. Bredt konfidensinterval. 9

10 4. Historiske comparator som der ikke er justeret for. 5. Der er ikke kontrolleret for potentielle confoundere. 6. Data baseret på spørgeskemaer. Lille responsrate. 7. Der anvendes LapraTy i studiearmen med sutur uden modhager. Det kan give et upræcist billede af operationstiden i forhold til andre suturmetoder. 10